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This specification covers all single-use clinical thermometer probe covers and sheaths intended for use with any clinical thermometer. Requirements are given for safety, toxicity, handling, labeling, and physical integrity. Testing procedures for appropriate requirements and a glossary of terms used are provided. Toxicity test, leakage test, and compatibility test shall be performed to meet the requirements prescribed.
This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.
1.1 This specification covers all single-use clinical thermometer probe covers and sheaths intended for use with any clinical thermometer. Requirements are given for safety, toxicity, handling, labeling, and physical integrity. Testing procedures for appropriate requirements and a glossary of terms used within the standards are provided.
1.2 The requirements contained herein are intended to ensure adequate isolation of the patient from the temperature-measuring device. In addition, the safety and health of the patient shall not be adversely affected. When used in accordance with the manufacturers instructions, the probe cover, sheath, and temperature measuring device shall remit correct temperature readings as required in Specifications E 667
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
E344 Terminology Relating to Thermometry and Hydrometry
E667 Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers
E1112 Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
ICS Number Code 11.040.99 (Other medical equipment); 17.200.20 (Temperature-measuring instruments)
UNSPSC Code 42182205(Medical thermometer tip or probe covers)
ASTM E1104-98(2009), Standard Specification for Clinical Thermometer Probe Covers and Sheaths, ASTM International, West Conshohocken, PA, 2009, www.astm.orgBack to Top